Daré Bioscience, Inc. develops therapies in the areas of contraception, pelvic pain, fertility, infectious disease, menopause, and sexual and vaginal health in the United States. The company offers XACIATO, a lincosamide antibacterial gel for the treatment of bacterial vaginosis. It also develops Ovaprene, a hormone-free monthly intravaginal contraceptive; Sildenafil Cream, a cream formulation of sildenafil for topical administration to the female genitalia for the treatment of female sexual arousal disorder; DARE-HRT1 to treat vasomotor symptoms in menopausal hormone therapy; DARE-VVA1 for the treatment of dyspareunia or pain during sexual intercourse; and DARE-HPV, a fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert to treat genital human papillomavirus (HPV) infection, cervical intraepithelial neoplasia, and other HPV-related pathologies. In addition, the company develops DARE-PDM1, a hydrogel formulation of diclofenac for vaginal administration to treat primary dysmenorrhea; DARE-204 and DARE-214, injectable formulations of etonogestrel that provides contraception over 6-month and 12-month periods; DARE-FRT1, an intravaginal ring designed to deliver bio-identical progesterone for luteal phase support as part of an in vitro fertilization treatment plan; and DARE-PTB1 for the prevention of preterm birth. Further, it develops DARE-LARC1, a contraceptive implant delivering levonorgestrel with a woman-centered design controlled contraceptive option; DARE-RH1, an approach to non-hormonal contraception for men and women by targeting the CatSper ion channel; DARE-PTB2 for the prevention and treatment of idiopathic preterm birth through inhibition of a stress response protein; DARE-LBT, a vaginal thermosetting gel formulation for the delivery of live biotherapeutics; and DARE-GML, which delivers antimicrobial glycerol monolaurate intravaginally. Daré Bioscience, Inc. was founded in 2015 and is headquartered in San Diego, California.
Dare Bioscience Announces New U.S. Patent Strengthening DARE-HPV Program as a Potential First FDA-Approved Pharmacologic Treatment for HPV Infection
Daré Bioscience announced issuance of U.S. Patent No. 12,678,439 covering topical lopinavir/ritonavir compositions for treating HPV-related cervical pathologies, which Daré exclusively licenses from Douglas Pharmaceuticals.
The patent extends DARE-HPV intellectual property protection into at least 2039, reinforcing its potential position as the first FDA-approved pharmacologic treatment for persistent high-risk HPV infection.
The Phase 2 study of roughly 100 women is underway with topline results expected in 2027; development is supported by approximately $10 million in non-dilutive ARPA-H funding plus a $2.0 million NIAID award.